A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis (EQUATOR)

April 20, 2018 updated by: Galapagos NV

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • ULB Hopital Erasme, Service de Rheumatology
  • Bulgaria
      • Plovdiv, Bulgaria
        • UMHAT "Kaspela", EOOD
      • Ruse, Bulgaria
        • MHAT - Ruse, AD
      • Sofia, Bulgaria
        • UMHAT "SofiaMed", OOD, Block 1
      • Sofia, Bulgaria
        • UMHAT "Sv. Ivan Rilski", EAD
  • Czechia
      • Pardubice, Czechia
        • CCBR Czech, a.s
      • Uherské Hradiště, Czechia
        • MEDICAL Plus s.r.o.
  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Centre Foundation
      • Tallinn, Estonia
        • OU Innomedica
      • Tallinn, Estonia
        • Center for Clinical and Basic Research
  • Poland
      • Nowa Sól, Poland
        • Twoja Przychodnia-Centrum Medyczne Nowa Sol
      • Poznań, Poland
        • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
      • Toruń, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
      • Warsaw, Poland
        • Centrum Medyczne AMED, Warszawa Targowek
  • Spain
      • Fuenlabrada, Spain
        • Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
      • Sevilla, Spain
        • Hospital Infanta Luisa, Servicio de Reumatologia
  • Ukraine
      • Kharkiv, Ukraine
        • CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
      • Kiev, Ukraine
        • CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
      • Kiev, Ukraine
        • SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
      • L'viv, Ukraine
        • CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
      • Poltava, Ukraine
        • M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
      • Ternopil', Ukraine
        • CI of TRC
      • Vinnytsya, Ukraine
        • MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
      • Vinnytsya, Ukraine
        • M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
      • Vinnytsya, Ukraine
        • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
  • Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
  • Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
  • Have had a history of documented plaque psoriasis or currently active plaque psoriasis
  • If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
  • If using non-drug therapies (including physical therapies), thse should be kept sable during screening
  • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol

Key Exclusion Criteria:

  • Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
  • Prior use of more than one TNF inhibitor, at any time.
  • Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to Baseline;
  • Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
  • Use of more than 1 NSAID or cyclooxygenase-2 (COX-2) inhibitor.
  • Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
  • Presence of very poor functional status or unable to perform self-care.
  • Administration of a live or attenuated vaccine within 12 weeks prior to baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Drug: Placebo Oral Tablet
one placebo oral tablet q.d.
Experimental: filgotinib
Drug: filgotinib
one filgotinib oral tablet q.d.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects who have reached ACR20 response as compared to placebo
Time Frame: Week 16
To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on MDA in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR50 response as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR70 response as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving DAS28(CRP) score as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving SDAI response as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving CDAI response as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients
At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving EULAR response as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on PsARC in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of physician's and patient's global assessment of disease activity as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on physician's and patient's global assessment of disease activity in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on on PsA pain intensity in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on joint tenderness and swelling in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of CRP in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filogotinib on CRP in PsA patients
At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on PASI in PsA patients
At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on PASI50 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the affect of filgotinib on PASI75 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the affect of filgotinib on PASI90 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the affect of filgotinib on PASI100 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the affect of filgotinib on Physician's and patient's global assessment of psoriasis in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of mNAPSI in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on mNAPSI in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on NRS in PsA patients
At each visit from screening until the final follow up visit (week 20)
Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients
At each visit from screening until the final follow up visit (week 20)
Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on Dactilytis in PsA patients
At each visit from screening until the final follow up visit (week 20)
Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on physical function in PsA patients
At each visit from screening until the final follow up visit (week 20)
FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of SF-36 in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on SF-36 in PsA patients
At each visit from screening until the final follow up visit (week 20)
Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo
Time Frame: At each visit from screening until the final follow up visit (week 20)
To assess the effect of filgotinib on PsAID in PsA patients
At each visit from screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment
Time Frame: From screening until the final follow up visit (week 20)
To evaluation safety and tolerability of filgotinib in PsA patients
From screening until the final follow up visit (week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pille Harrison, MD, DPhil, MRCP (UK), Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLPG0634-CL-224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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